Despite Law, Fewer Than One In Eight Completed Studies Of Drugs And Biologics Are Reported On Time On ClinicalTrials.gov

Abstract

Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.

Peering into the “rabbit hole” of publication bias and inadequate research transparency: Adding tangibility to the abstract

“…[67][68][69][70][71][72] Similarly, ClinicalTrials.gov and the reporting mandate in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA of 2007) have also failed, and the changes proposed in late 2014 by the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) unfortunately do not provide any material assurance of rectifying these issues. [73][74][75][76][77][78][79][80][81][82][83][84][85][86] On the surface, the changes are desirable, as they call for an expansion in what exactly must be reported. Notably, however, the changes do nothing to address clinical trials that occurred before the FDAAA of 2007 initially went into effect; the changes are still reliant on the FDAAA of 2007, which has quite simply never been enforced; the changes would actually expand the responsibilities for enforcement even though there was a complete failure to enforce the FDAAA of 2007 in its original form; and the changes do not provide any explanation for the non-enforcement issue or any assurance of enforcement going forward.…”

“…Notably, however, the changes do nothing to address clinical trials that occurred before the FDAAA of 2007 initially went into effect; the changes are still reliant on the FDAAA of 2007, which has quite simply never been enforced; the changes would actually expand the responsibilities for enforcement even though there was a complete failure to enforce the FDAAA of 2007 in its original form; and the changes do not provide any explanation for the non-enforcement issue or any assurance of enforcement going forward. [73][74][75][76][77][78][79][80][81][82][83][84][85][86] On the other hand, the AllTrials initiative (www.alltrials.net) -a joint initiative of (in alphabetic order): Bad Science, The BMJ, the Centre for Evidence-based Medicine, the Cochrane Collaboration, the James Lind Initiative, PLoS, and Sense About Science -has gained much momentum since its launch in 2013, and it continues to fight in this arena. [87][88][89] It is being led in the U.S. by Dartmouth's Geisel School of Medicine and the Dartmouth Institute for Health Policy and Clinical Practice, with the official launch in the U.S. occurring just this year in late July.…”

Pharmacologic Treatment of Repetitive Behaviors in Autism Spectrum Disorders: Evidence of Publication Bias

“…Identifying effective treatments for these patients will be difficult if partial and selective publication of clinical trials persists, an issue that experts indicate is widespread across all fields of medicine, is not specific to industry or academia (but plagues both), and that may be best addressed with greater enforcement of the registration and reporting of all clinical trials and their results. 59 …”

ClinicalTrials.Gov: Is the Glass Half Full?

“…Thirty-nine percent of clinical trials are registered late, even after the mandate's deadline. 17 Additionally, the recent trend in which more clinical trials are being conducted overseas has added to the complexity, because US federal mandates have no jurisdiction over other countries. 17 Second, more stringent and strongly enforced registration requirements will likely be necessary to decrease the incidence of incomplete reports, catch retrospective changes to study results, and increase the reporting of important fi ndings that may otherwise go unnoticed.…”

“…17 Additionally, the recent trend in which more clinical trials are being conducted overseas has added to the complexity, because US federal mandates have no jurisdiction over other countries. 17 Second, more stringent and strongly enforced registration requirements will likely be necessary to decrease the incidence of incomplete reports, catch retrospective changes to study results, and increase the reporting of important fi ndings that may otherwise go unnoticed. Most importantly, the trial sponsors are morally obligated to furnish complete and meaningful reports for the sake of patients who take a signifi cant health risk to participate in clinical trials.…”